The Chromosome Pathology Section generated a valuable resource not previously available at the NIH as it is a cost-efficient alternative for investigators who were previously required to order expensive FISH testing required for clinical protocol eligibility from reference laboratories. More importantly, the laboratory represents a bench-to-bedside bridge that keeps pace with the latest discoveries in cancer research, bringing new discoveries to clinical patient testing more rapidly than would be available from reference laboratories (the R&D component of the CPU). That includes novel methods such as molecular imaging using spectral microscopy imaging of unstained tumor sections The CP is not just a clinical laboratory, it actively participates in research collaborations with other investigators within CCR and other NIH Institutes to promote basic and clinical research. The Chromosome Pathology Section in the Laboratory of Pathology performs Fluorescence In Situ Hybridization (FISH) assays on formalin-fixed paraffin-embedded (FFPE) tissues to support active clinical trials at the NCI and NIH. The FISH lab was opened in 2010 to fulfill the need in the in house laboratory FISH tests required to support clinical trials at NCI. The official CAP accreditation and CLIA certification has been accomplished by the CP team in November 2010. From January 2011 the lab started receiving clinical cases for FISH testing. The CPU performed more than 10,000 tests since its opening. This includes FISH assays for over 2000 clinical reported tests, over 8000 tests for probe validation and collaboration with LP and other NIH researchers. FISH diagnostics are an integral part of the Pathology molecular diagnostics currently offered by the Lab of Pathology. The sensitivity and specificity of FISH diagnostics was found to be near 100% in recent reports of CAP that puts them in front line among other available tests based on PCR and immunohistochemistry that have a long-known specificity problem. The demand for this testing is high; the CPU receives orders for FISH tests on clinical tumor samples daily, and currently supports 16 clinical trials at the NCI. That includes requests from the entire community of CCR investigators: Neuro-Oncology Branch, Thoracic & GI Oncology Branch, Vaccine Branch, Experimental Transplantation and Immunology Branch, Surgery Branch, Urologic Oncology Branch, Office of the Director. The active test menu includes FISH assays for clinically significant chromosomal translocations and amplification events in solid tumors and hematologic malignancies. The developed/ validated tests include 1p/19q deletion tests for brain tumors Her-2 amplification in Breast, Lung, and GI tract cancer, c-myc translocation in Burkitt and Diffuse Large B Cell Lymphoma, BCL2 translocation in Follicular Lymphoma, ALK translocation in lung cancer and inflammatory myofibroblastic tumors, TFE-3 translocation in renal tumors, alveolar soft part sarcoma, EWSR1/FLI1 and FOXO1translocations in pediatric tumors (Ewing's sarcoma and Rabdomyosarcoma), etc. In addition, the CPU is currently developing and validating ten new FISH tests for additional frequent chromosomal abnormalities in cancers that have been requested by NCI investigators. Among the tests in the pipeline are UroVysion, PD-L1, MDM2, MDM4 gene amplification tests for urothelial cancer. The CP group has been working on developing novel diagnostics that would significantly advance currently existing approaches in cancer clinical testing. One of them is isolation and molecular profiling of the circulating tumor cells (CTCs) from the peripheral blood of cancer patients as an alternative non-invasive biopsy method for detection and monitoring tumor metastatic disease and treatment efficiency. The unit has been equipped as state-of-the art laboratory that includes a new automated Fluorescence imaging workstation Duet from BioView. Inc, Zeiss epifluorescence microscope with the ApoTome feature that allows FISH analysis and imaging of thick tissue sections, SKY-cube for spectral karyotyping - a modern tool for the detection of chromosomal translocations in cancer cells and various hereditary syndromes.